NCT05315661

The Safety and The Efficacy Evaluation of ET-STEM in Patients With Frontotemporal Dementia

Clinical Assessment on the Safety and Potential Efficacy of Mesenchymal Stem Cells Preconditioned With Ethionamide (ET-STEM) in Patients With Frontotemporal Dementia (FTD)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the safety and the tolerability of 3 repeated doses of ET-STEM (Mesenchymal stem cells preconditioned with ethionamide) in patients with FTD.

Detailed description

Subjects with FTD, who signed the informed consent form and meet the eligibility criteria will undergo Ommaya reservoir insertion. 2 weeks after Ommaya reservoir insertion, the subjects will be injected with 3x10\^7 cells/2mL of ET-STEM to intraventricular space via an Ommaya reservoir. The injection will be repeated 3 times at 4 week intervals. The subjects will be hospitalized for 24 hours and observed for acute adverse events. 4 weeks after the 3rd injection, safety and potential efficacy will be assessed.

Conditions

• Frontotemporal Dementia

Interventions

Type	Name	Description
DRUG	ET-STEM	mesenchymal stem cells preconditioned with ethionamide

Timeline

• Start date: 2022-07-06
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-04-07
• Last updated: 2024-02-21

Locations

1 site across 1 country: South Korea